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Showing 2121–2140 of 68218 results

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Peak Cocktails Blood Orange Spritz (Peak Cocktails) – Exploding Cans (2025)

Overpressurization leading to exploding cans

Class IIModerate

FDAJun 3, 2025AL, AK, AZ +47 more• Peak Cocktails

BD Heyman Follower Coude Tip (C.R. Bard) – Catheter Size Incorrect (2025)

Cather packaging may contain the incorrect French size.

FDAJun 3, 2025Nationwide• C.R. Bard Inc

EMPOWR 3D Knee Insert (Unknown) – Packaging Discrepancy (2025)

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.

Moderate

FDAJun 2, 2025AZ, ID, IL +15 more

Medshape Universal Joints (Medshape) – Frame Instability Risk (2025)

Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.

FDAJun 2, 2025Nationwide• Medshape, INC.

Pizza Shoppe Pink Stuff Garlic Dressing (La Fontanella) – Potential Spoilage (2025)

Potential for product spoilage (increased level of lactic acid detected in retain samples).

Class IIModerate

FDAJun 2, 2025IN, IA, KS +1 more• La Fontanella Food Products LLC

Windsor Himalayan Pink Salt Grinder (Morton Salt) – Incorrect Weight (2025)

The quantity of product in each unit does not match the stated weight.

FDAJun 2, 2025IN• MORTON SALT INC

Rocky Road Ice Cream (Unilever) – Mislabeled Allergens (2025)

Undeclared Allergen

Undeclared allergens and mislabeled product. Rocky Road Ice was packaged with Chocolate Truffle Ice Cream labeled tub and a Rocky Road Ice Cream lid. Tub said "may contain tree nuts" the lid said it did contain almonds.

Class IIModerate

FDAJun 2, 2025Nationwide• Unilever Manufacturing (US), Inc.

Sulfamethoxazole Trimethoprim Tablets (Amneal) – Microbial Contamination (2025)

Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial contamination.

FDAJun 2, 2025Nationwide• Amneal Pharmaceuticals, LLC

Lidocaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride 50mg Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCL with Epinephrine Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Ketamine Hydrochloride Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Bupivacaine HCL Sterile Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Lidocaine HCl Injection (Tailstorm Health) – Sterility Concerns (2025)

Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufacturing process.

Class IIModerate

FDAJun 2, 2025Nationwide• Tailstorm Health INC

Windsor Extra Course Sea Salt Grinder (Morton Salt) – Incorrect Weight (2025)

The quantity of product in each unit does not match the stated weight.

FDAJun 2, 2025IN• MORTON SALT INC

Eudos Bronquilan (Nature's Eudos) – Undeclared Colors (2025)

Undeclared Allergen

Undeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)

Class IIModerate

FDAJun 1, 2025NJ, NY• Nature's Eudos Distributors LLC

Platelia Toxo IgM (Bio-Rad) – False Positive Results (2025)

Due to a risk of false positive results that could lead to unnecessary medical treatment.

FDAMay 30, 2025Nationwide• Bio-Rad Laboratories, Inc.

Servo-u MR Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

Hillrom Q-Link 13 Component (Baxter Healthcare) – False Attachment Risk (2025)

The Q-link 13 could allow for an improper attachment (false latching) of the Quick-Release Hook used on Sling Bars and other accessories. This could result in a critical injury from a patient fall as the false latched component may initially bear weight but can loosen from the Q-link resulting in a detachment and drop.

FDAMay 30, 2025Nationwide• Baxter Healthcare Corporation

Servo-u Ventilator (Maquet) – Patient Circuit Test Error (2025)

Potential for inaccurate measurement of the patient circuit compliance during the patient circuit test due to combination of incorrect pre-use leakage test and use of an incorrect active humidifier.

FDAMay 30, 2025Nationwide• Maquet Critical Care AB Rontgenvagen

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